NeuroThera Labs Inc. initiated a Phase IIb clinical trial site at the Yale Child Study Center in New Haven, evaluating SCI-110, a cannabinoid-based drug candidate for Tourette Syndrome in adults. The trial, led by Dr. Michael H. Bloch, is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel.
NeuroThera Labs Inc. is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations.
SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in a single dosage form designed to reduce tics and associated comorbid symptoms in adults with Tourette Syndrome (TS) while aiming to minimize side effects.
The Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial evaluating SCI-110's efficacy, safety, and tolerability in patients aged 18 to 65, randomized to receive SCI-110 or placebo. The primary efficacy endpoint is change in tic severity at weeks 12 and 26 compared to baseline, measured by the Yale Global Tic Severity Scale, with safety assessed through adverse event monitoring.
The Yale Global Tic Severity Scale (YGTSS) is the standard tool doctors use to measure the severity of tics in people with Tourette's Syndrome and related conditions. Tics are sudden, involuntary movements, like rapid blinking or jerking the head, that often begin in childhood and tend to flare up during stress or tiredness. Many people feel a strange urge before a tic happens, similar to needing to scratch an itch, and can sometimes hold the tic back briefly. Tics most often affect the face, head, neck, and shoulders, and they can change over time, with new tics replacing old ones every few weeks or months.
Phase IIa results showed an average tic reduction of 21% across the study sample, measured by the Yale Global Tic Severity Scale Total Tic Score.
Dr. Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, said, "Launching a U.S. site at the Yale Child Study Center represents a significant milestone in our global development program for SCI-110. TS remains a major unmet medical need with limited therapeutic options, particularly in adults who continue to experience persistent, severe, and often debilitating symptoms. We believe SCI-110 has the potential to introduce a novel, more effective and safer treatment approach. We are deeply committed to advancing this promising therapy and generating meaningful clinical data to support its future regulatory approval."
